510(k) · Cleared
ClearedVital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DQA Oximeter
Cleared on Dec 27, 2010 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 27, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK102835 Vital Signs MonitorEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK120144 Vital Signs MonitorEdan Instruments, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK113653 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK180380 vital signs monitorEdan Instruments, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK123048 Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120144Vital Signs MonitorEdan Instruments, Inc. · 2012 · cites it directly2descendants
- K131818Vital Signs MonitorEdan Instruments, Inc. · 2013 · 2 generations on1descendant
- K113653Patient MonitorEdan Instruments, Inc. · 2012 · cites it directly1descendant
- K180380vital signs monitorEdan Instruments, Inc. · 2018 · 3 generations on0descendants
- K123048Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProAdvanced Instrumentations, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102835 | Vital Signs Monitor | Edan Instruments, Inc. | 2010 | — |
| +1 | K120144 | Vital Signs Monitor | Edan Instruments, Inc. | 2012 | — |
| +2 | K131818 | Vital Signs Monitor | Edan Instruments, Inc. | 2013 | 2 |
| +1 | K113653 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +3 | K180380 | vital signs monitor | Edan Instruments, Inc. | 2018 | 1 |
| +2 | K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A Pro | Advanced Instrumentations, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120144 (Edan Instruments, Inc., 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
https://510kreport.com/device/K102835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102835: Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102835
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026